Alexion Win Thwarts Roche’s EU Fast-Track Hopes
Roche hopes that its investigational drug satralizumab for neuromyelitis optica spectrum disorder will win EU approval in the second half of 2020.
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The European Medicines Agency has finally recommended pan-EU marketing approval for Roche’s Enspryng.
Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.
With Alexion's Soliris already approved, and Viela's inebilizumab within touching distance of an FDA green light, Roche is highlighting the safety profile of its investigational neuromyelitis optica spectrum disorder drug satralizumab.